Global evidence of persistent violations of the International Code of Marketing of Breast‐milk Substitutes: A systematic scoping review

Abstract The influence of marketing on infant and young child feeding and health is well recognized, and an International Code was adopted by the World Health Assembly (WHA) in 1981 to reduce inappropriate marketing and protect breastfeeding. Yet the marketing and influencing continue. This scoping review systematically examined the published research evidence on the nature and extent of exposure to International Code violations from 1981 to August 2021. We used several search strategies involving multi‐language databases, organization websites, citation tracking, and expert consultation, to find research items meeting our inclusion criteria. We evaluated 657 items and retained 153 studies from at least 95 countries in the review. The majority of the studies (n = 113) documenting exposure to inappropriate marketing were published since 2010. Studies reported a broad range of marketing violations targeting mothers and families, health workers, and the general public. Marketing via digital platforms and brand extension has become more frequent. The evidence shows the use of misleading and inaccurate labeling and health and nutrition claims in breach of the Code. Our review confirms that violations of the Code have not ceased and calls for renewed attention from the WHA and national governments to protect the health of children and their mothers.


| INTRODUCTION
Corporate efforts to weaken public health policies and influence research and practice to increase corporate profits are recognized across a range of products that contribute to ill-health (Mialon, 2020;World Health Organization, 2013). Though the term "commercial determinants of health" may be recent (Kickbusch et al., 2016), awareness of the overall concept that marketing and other corporate strategies influence the knowledge, attitudes, and behaviors of pregnant women and new mothers, her family, and friends, the general public, health workers, and of policymakers is not new.
Inappropriate marketing, namely, promotion, of breastmilk substitutes (BMS) by the baby food industry negatively impacts immediate and long-term health outcomes for mothers and children as well as household and community socioeconomic status (Piwoz & Huffman, 2015;Rollins et al., 2016;Walters et al., 2019).
Recognition of the negative health effects of this marketing The Code, together with subsequent relevant resolutions to date (hereafter collectively referred to as "the Code"), apply to all products that are marketed or represented as a suitable partial or total replacement of breastmilk, including any milk products marketed for feeding infants and young children up to 3 years of age, other foods and beverages marketed as suitable for feeding infants less than 6 months or for feeding on a bottle. The Code also applies to feeding bottles and teats, and complementary foods marketed for children up to 3 years of age. The Code calls on all Member States to ensure that effective, objective, independent, and transparent monitoring systems are in place to enforce the Code's standards and recommendations. It is also a part of global guidance and recommendations to reduce the impact of food marketing on child health (World Health Organization, 2020).
With the aim to protect breastfeeding and optimal IYCF, the Code prohibits the promotion of covered products (with the exception of commercial complementary foods of which only some forms of promotion are restricted), including promotion to the general public, health workers, and mothers; via media, provision of gifts and incentives to health workers and to mothers, use of health claims and cross-promotion between complementary foods and BMS. Donations or low-cost supplies of BMS to health services and in emergency situations, donated equipment to health care facilities, financial support for conferences, provision of education sessions, and other incentives are also prohibited, as these can all serve to build goodwill within the health system and with the public, increase the use and potentially expand the market of the products, while also creating conflicts of interest. Despite assertions by the industry that BMS companies are compliant with the Code (Nestlé, 2018) and commentary that marketing does not influence feeding practices (Bognar et al., 2020;Forsyth, 2013), numerous recent studies indicate that promotion through advertisement, gifts, sponsorship, cross-promotion, and inappropriate labeling remains a problem with negative effects on infant feeding attitudes and behaviors (Berry et al., 2010;Boyle & Shamji, 2021;Ching et al., 2021;Hastings et al., 2020;Save the Children, 2018

| METHODS
This systematic scoping review followed the Joanna Briggs Institute guidelines (Peters et al., 2020, chap. 11) and is reported in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) extension for Scoping Reviews (Tricco et al., 2018). The six-step process of Arksey and O'Malley (Arksey & O'Malley, 2005) formed the framework and a protocol was published (Becker et al., 2021). The overall research question was identified as: What is the published evidence of exposure to violations of the International Code of Marketing of Breast-milk Substitutes?
An international consultative group, including researchers and persons involved in guidance and monitoring of Code implementation, was consulted at the protocol stage to develop the research question, plan the search strategy, discuss data elements to be charted and key elements to report; then to review the list of Included and Excluded items after the screening phase to ensure no key documents were missed, and to comment on our findings before publication.
Search terms were developed from an analysis of keywords in known articles relevant to the Code, BMS, violation/compliance, and marketing. The search strategy was designed to be geographically broad and extend over four decades rather than aiming for saturation, and to provide the review in a timely manner. Studies were considered with data collected or published from May 1981 (the date when the WHA adopted the Code) until July 2021. No limitations were set for geographical location, country income level, social or cultural group, language, setting in which the violation occurs, or journal impact factor. The authors of this study include proficient speakers of Chinese, Spanish, French, and Portuguese as well as English. Documents in languages other than these five languages for which the abstract could be translated adequately using Google translate were included for screening with the full text translated as needed. Studies were considered from settings including but not limited to retail, health care, emergency or relief settings and/or directed at any group (pregnant women, new mothers, health workers, and general public), and/or via any means (leaflets, digital media, free samples, etc.).
A screening tool was developed and tested, and abstracts were independently screened by two members of the team. Eligibility for inclusion required that all three criteria were met: 1. Document is a primary report of a systematic investigation, including a research question or problem, method of enquiry, analysis method, and reporting of findings.
2. Document reports on specific violation(s) of the Code.
3. Document reports on one or more specific context(s), setting(s), or means of marketing.
Opinion papers, policies, guidelines, reviews, and studies solely focused on the effects of violations were excluded. Multiple reports of the same study were combined as one item of evidence. Pacifiers and commercial milk formula for pregnant women or lactating women are not currently within the scope of the Code however they are an increasing means of cross-promotion, undermining breastfeeding, and therefore we included them in this review.
A data charting tool for eligible studies was prepared using headings determined at the protocol stage (Supporting Information Appendix A: Charting headings) to answer key research aspects: • What types of published research examined Code violations?
• When were the studies conducted?
• How geographically widespread were the studies?
• In which settings did the violations occur?
• Who were the targets of violations?
• What are the types of violations reported?
• What products were involved in the violations?
The charting tool was piloted, and five studies were charted together to develop consistency. Team members independently reviewed their assigned studies with all items second charted by another team member to facilitate accuracy, with any disagreements discussed between the two team members.
The spreadsheet charting tool was used for the basic numerical analysis and summarised in tabular format with simple descriptive statistics as relevant. The studies are described, and findings are reported as a thematic narrative summary linked to the seven aspects of the research question.

| RESULTS
The four search sources identified 1301 items, which after the electronic database de-duplication process resulted in 657 items to be screened for eligibility. The screening process resulted in 153 studies eligible for charting (data extraction; Figure 1; Supporting Information Appendix B: List of eligible studies). Table 1 summarises the studies included in our review published from the adoption of the Code in 1981 to mid-2021.

| Types of published research that examined Code violations
Most studies were published in peer-review journals (59%; n = 91) in various formats. When a funding source was disclosed, it was most commonly a philanthropic foundation (n = 32). No study disclosed major funding from a company producing BMS; two studies noted funding in the form of an individual research grant from the industry to one of the researchers  and partfunding of another study (Popkin et al., 1990); these two studies were included in the review.
A variety of data collection methods were used to document Code violations. An observation tool or checklist was the most BECKER ET AL. | 3 of 14 common method of data collection with three global pre-existing tools used in 59% of the studies that used survey tools. Pregnant women and/or mothers were the most sampled population for interviews. Study size ranged from examination of a single product or information source and small studies using qualitative interviews to very large quantitative studies. The studies also reported other settings where Code violations occurred, including emergency programs and government and NGO programs (n = 13), public spaces (such as billboards on roads and public transport; n = 12), health workers' training and education (n = 10) and daycare facilities and schools (n = 5). Some studies examined more than one setting and each setting is counted separately.

| Targets of inappropriate marketing
Mothers of infants and young children were the most frequently identified target of BMS marketing (134 studies, 87.5%; Figure 4).
Health facility staff, health professionals (including students), and professional associations were the next most common target followed by pregnant women, then fathers, caregivers and families, and the general public. Other targets included retail staff in pharmacies and shops, policymakers and government officials, school children, and researchers. Violations targeting mothers, pregnant women, health workers, and fathers, caregivers, and families were identified in studies across all decades. Many studies in our sample reported marketing across multiple target groups and we counted each target group separately.

| Types of Code violations reported in studies
The wide range of Code violations reported in the studies was categorized into types broadly based on the relevant Articles (Art.) in the Code and WHA resolutions (Res.). Some studies reported more than one type of violation and each type is counted separately.
As shown in Table 2 (Laillou et al., 2021). Promotion via parent magazines was highlighted in a study in Taiwan (Chen) and in a Chinese study "premiumization" and "nutrition and science" were the main marketing appeal strategies on the BMS companies' websites and e-commerce platforms studied (Han, 2020).  help with digestion, support for cognitive development and aid to the immune system in an Australian study (Berry & Gribble, 2017).

Types of violations
Promotion of feeding bottles and teats also included claims such as "proven to reduce colic" reported in Uruguay (Alcaire et al., 2020).
Marketing activities in health care settings and through health workers were numerous with many studies reporting more than one type of Code violation. For example, marketing activities related to scholarships, sponsorship of conferences and other events, or using a health facility to hold a marketing event were reported in countryspecific studies from Chile (Achurra & Salinas, 1993  , Vietnam , Pakistan (Salasibew et al., 2008) and India (Gupta, 2021). These marketing activities were also found in studies carried out in 14 countries , 5 continents (Grummer-Strawn et al., 2019), 3 continents (Hastings et al., 2020), and in many countries included in the Breaking the Rules reports (Yeong & Allain, 2001, 2004.

| Products involved in the studies of Code violations
Many studies identified more than one product being marketed and we counted these separately. Infant formula (including formula marketed as "specialized") comprised the largest proportion of all products documented across all decades, though showing a decreasing trend. We found an increase in the proportion of studies reporting inappropriate marketing of follow-up formula and "growing-up" or "toddler" milk from one study and no studies before 1990 to 59% and 53%, respectively, during the most recent decade (Table 3).
that undermines breastfeeding, in particular cross-branding strategies that indirectly promote BMSs . Our findings show that mothers and pregnant women continue to be among the most exposed to inappropriate marketing of products within the scope of the Code, but there is also substantial exposure among fathers, caregivers, and families. Marketing targeting the general public, including school children, help establish brand awareness, to normalize the use of BMS and commercially prepared complementary foods as well as to increase social acceptance of these products. Support from health workers and within the health system is a well-established determinant of IYCF practices (Matvienko-Sikar et al., 2019;McFadden et al., 2017;Pries et al., 2016). As a trusted source of health advice to parents, health workers are an important target group for marketing, and health facilities are a long-standing and major setting for the promotion of BMS Rothstein et al., 2020;World Health Organization et al., 2020). Engaging the medical establishment also results in promotion by association (Hastings et al., 2020). Studies documented gifts, sponsorships, and other financial incentives to health workers that create conflicts of interest and compromise the integrity of information and advice given to parents (Pries et al., 2016;Rothstein et al., 2020). An exploratory survey and focus group analysis in the Philippines found that physicians' recommendations and selfreported exposure to advertising were strongly associated with formula use (Sobel et al., 2011).

| DISCUSSION
Retail is a major setting for BMS promotion and there is no mention in the Code of restrictions on marketing activities by companies to retail staff. Studies reported BMS companies training retail staff, including staff in pharmacies, on how to market their products and offering these staff sales incentives (Baby Milk Action UK, 2017;Oliveira et al., 2021).
Online purchasing of IYCF products is becoming more common and provides an opportunity for advertising, special offers, and other marketing practices via these retail sites. Social networking sites sponsored by BMS companies and the use of paid bloggers or influencers in recent years (Abrahams, 2012;Senkal & Yildiz, 2019) make digital marketing interactive, personalized, and thus effective. It is less apparent but more insidious as a form of commercial marketing to pregnant women and parents as well as policymakers. WHA Feeding young infants with unsuitable products puts their health at risk. Studies reported that caregivers mistook labels and advertisements of products such as follow-on milk (marketed as suitable for 6-12-month olds) and "toddler" milk as formula suitable for young infants (Berry et al., 2010;Cattaneo et al., 2015). One large study in a low-income country found the same brand logo of a mother and baby bear used for both a sugar-based coffee creamer and a milk product for older babies, which confused parents that the creamer was also suitable for infant feeding (Barennes et al., 2008).
Feeding bottles and teats continue to be marketed in a manner that undermines breastfeeding, and insufficient label warnings and safety instructions create potential health risks for infants using these products.
Our findings are consistent with the product development and subsequent differentiation of BMS since the adoption of the Code in BECKER ET AL. Our review focused on the exposure of mothers, health workers, retail staff, and other individuals to marketing. However, marketing is multi-faceted and aims to influence attitudes and behaviors. A person's understanding or perception of the products and the marketing may be as important as its occurrence and warrants review. Mothers (and other caregivers) have indicated confusion between BMS products being marketed (Barennes et al., 2008;Berry et al., 2010;Cattaneo et al., 2015) and health service and BMS industry interactions may be so normalized that the effect is not recognized (Bognar et al., 2020). It would be valuable to also collate the global research evidence on the effect of inappropriate marketing on family and national economics and environmental impact (Dadhich et al., 2021;Long et al., 2021;Smith, 2015;Walters et al., 2019) towards building the knowledge and developing coordinated multi-faceted solutions.

| Limitations
Our search may not have captured studies not accessible in online databases or that were published in languages not commonly found in major search databases, or from researchers without the resources for publication. This was mitigated by our search of multiple databases, no search restrictions to languages, reference checks, and through consultation with the international consultative group.
However, it is not an exhaustive documentation of studies examining Code violations. Our focus was the research evidence of exposure to violations of the Code and did not review national legislation implementing and enforcing the Code.

| CONCLUSION
Our systematic scoping review shows that four decades from the and social media will contribute to further discussion and activity on the topic, serve to inform international and national decision-makers, provide helpful insight to strengthen Code implementation, monitoring, and enforcement, and thus contribute to protecting the health of infants and young children and their mothers.